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Last Updated: March 19, 2024

LAMOTRIGINE Drug Patent Profile


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Which patents cover Lamotrigine, and what generic alternatives are available?

Lamotrigine is a drug marketed by Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa. and is included in forty-nine NDAs.

The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lamotrigine

A generic version of LAMOTRIGINE was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.

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Drug patent expirations by year for LAMOTRIGINE
Drug Prices for LAMOTRIGINE

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Drug Sales Revenue Trends for LAMOTRIGINE

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Recent Clinical Trials for LAMOTRIGINE

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SponsorPhase
Dr. Inge WinterPhase 4
Westfälische Wilhelms-Universität MünsterPhase 4
Dr Cipto Mangunkusumo General HospitalPhase 4

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Anatomical Therapeutic Chemical (ATC) Classes for LAMOTRIGINE
Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LAMICTAL XR Extended-release Tablets lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg 022115 1 2014-02-12
LAMICTAL ODT Orally Disintegrating Tablets lamotrigine 25 mg, 50 mg, 100 mg, and 200 mg 022251 1 2009-12-21

US Patents and Regulatory Information for LAMOTRIGINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva LAMOTRIGINE lamotrigine TABLET, FOR SUSPENSION;ORAL 076420-001 Jun 21, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Totowa LAMOTRIGINE lamotrigine TABLET;ORAL 078669-003 Apr 8, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt Bio Ag LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202498-003 Jan 4, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 202887-002 Jun 17, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro Pharm Inds LAMOTRIGINE lamotrigine TABLET;ORAL 078525-002 Jan 27, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane LAMOTRIGINE lamotrigine TABLET;ORAL 077392-004 Jan 27, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amring Pharms LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 214124-004 Feb 3, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.